The present invention relates generally to novel pharmaceutical compositions of matter comprising one or more non-steroidal anti-inflammatory drugs (NSAID) in combination with a non-sedating antihistamine and optionally one or more other active components selected from a sympathomimetic drug (nasal decongestant, bronchodilator) cough suppressant and/or expectorant, optionally in combination with suitable pharmaceutically acceptable non-toxic carriers or excipient, and to methods of using said compositions in the treatment, management or mitigation of cough, cold, cold-like and/or flu symptoms and the discomfort, pain, headache, fever and general malaise associated therewith.
Applicants' earlier application, now U.S. Pat. No. 4,619,934 was directed to one or more NSAID's in combination with a conventional antihistamine and other optional components. Applicants have now discovered that the non-sedating antihistamines, which are pharmacologically and chemically distinct from the conventional antihistamines, in combination with one or more NSAID's offers significant advantages in the treatment, management or mitigation of cough, cold, cold-like and/or flu symptoms and the discomfort, pain, fever and general malaise associated therewith. It is well known that the conventional antihistamines may cause drowsiness or marked drowsiness. While this may be an advantage at bedtime, if taken during the day, the label recommends that a patient use caution when driving a motor vehicle or operating machinery. The combination of a non-sedating antihistamine and an NSAID is therefore particularly advantageous for daytime administration.
Non-narcotic analgesics, most of which are also known as non-steroidal anti-inflammatory drugs, are widely administered orally in the treatment of mild to severe pain. Within this class, the compounds vary widely in their chemical structure and in their biological profiles as analgesics, anti-inflammatory agents and antipyretic agents. Among the most commonly used members of the non-narcotic analgesic class of drugs are aspirin and acetaminophen. Aspirin, acetaminophen and salicylamide are among the drugs that have heretofore been included as the pain reliever and fever-reducing component in conventional cough/cold multisymptom alleviating compositions.
However, a number of alternative non-narcotic agents offering a variety of advantages over these conventionally employed non-narcotic analgesic antipyretics have now been developed. The principal advantages of these non-steroidal anti-inflammatory drugs include not only the clinically superior analgesic, anti-inflammatory and antipyretic activity of these agents compared to aspirin and acetaminophen, but also a minimization of the adverse side effects experienced with these conventional agents; more specifically, the gastrointestinal ulcerations experienced with aspirin and the hepatic toxicity prevalent with the chronic use of acetaminophen.
Exemplary prior art cough/cold formulations containing aspirin or acetaminophen include Coricidin.RTM., Coricidin D.RTM., Comtrex.RTM., Dristan.RTM., Daycare.RTM., Cotylenol.RTM., Sinubid.RTM. and the like. These formulations generally contain in addition to aspirin, acetaminophen or salicylamide, one or more conventional antihistaminics, decongestants, cough suppressants, antitussives and expectorants.
While aspirin and acetaminophen have been utilized in these previous compositions, it has not been heretofore proposed to use any of the newer non-steroidal anti-inflammatory drugs (i.e., excluding aspirin, acetaminophen and phenacetin) in the preparation of advantageous cough/cold pharmaceutical compositions.